FDA-Device2022-04-13Class II
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Maquet Cardiovascular, LLC
Hazard
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Sold states
Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.
Affected count
60
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0887-2022Don't want to check this manually?
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